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Request a Clinicaltrials.gov Account and Clinicaltrials.gov Support.

Guidance and Review of Issues related to Export Control Laws.

The IND/IDE Support Office offers assistance with FDA submissions.

Resources for completing Human Research Protection Program Training.

Send a copy of your protocol and pharmacy manual, if one is available.

Schedule IDS site visit and protocol training.

Notify the IDS when involvement is no longer necessary and schedule a closeout visit, if one is...

The IND/IDE Support Office provides guidance and training to Investigators regarding the...

Children's Hospital of Philadelphia Sponsor-Investigator Monitoring Resources.

Provides Required Peer Feedback for Investigator Held IND & IDE Protocols.

Determine whether an Investigational Device Exemption (IDE) is required for a study.

Determine whether an Investigational New Drug Application (IND) is required for a study.

Develop product prescribing and dispensing procedures for your study.

Support for Research Institute Administrative Policy Management.

Conduct quality assurance, education, and audit preparation activities.

To report compliance concerns anonymously, contact the Compliance Hotline 1-866-246-7456.

A Treatment IND/sIND allows an experimental drug (or biologic) to be used to treat a patient while...

View resources for completing undue foreign influence training.